Regulatory services

State-of-the-art products

Thanks to the experience we have gained during these decades in the pharmaceutical sector, we offer a series of auxiliary services in addition to manufacturing and packaging.

For medical devices, we offer support for regulatory services such as:

  • drafting of technical dossiers
  • drafting of clinical evaluations
  • registration with the Italian Ministry of Health database
  • CE certification for all European Union countries
  • Free sale certificate for distribution in non-EU countries

For pharmaceutical products, we offer support for regulatory services such as:

  • registration via national and European Union procedures
  • ANDA registration
  • drafting of e-CTDs to create e-CTD sequences
  • regulatory compliance
  • minor and major variations (evaluation and/or management)
Are you interested in this service?
We are specialized in
private label

We offer customers a complete range of medical devices for nasal and eye care, ready for customisation with the graphics and brand of the distributor.